Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD

This randomized, double-blind, placebo-controlled study (n=160) aims to evaluate the safety, tolerability, and efficacy of Psilocybin-Assisted Psychotherapy (APEX-002-A02) in treating severe depression among adults with Post-Traumatic Stress Disorder (PTSD).

Post-Traumatic Stress Disorder (PTSD) often coexists with depression and other psychiatric conditions, presenting a significant healthcare challenge. Traditional treatments often have limited efficacy and may be associated with adverse effects. Psilocybin, a compound found in certain mushrooms, has shown promise in treating depression and other symptoms associated with PTSD. This study seeks to further explore its therapeutic potential.

Participants, aged between 18 and 65, who meet DSM-5 criteria for current PTSD with symptoms lasting at least six months and have moderate PTSD and severe depression, will be recruited. They must also be fluent in English or French and willing to provide informed consent. Exclusion criteria include pregnancy, certain medical conditions, substance use disorders, and previous exposure to psilocybin beyond specified limits.

The study will employ a randomised allocation, with one group receiving APEX-002-A02 (psilocybin) and the other receiving a placebo. Both groups will undergo quadruple masking, where participants, care providers, investigators, and outcome assessors are unaware of the treatment allocation. Outcome measures include the incidence of adverse events, changes in severity of depressive symptoms, PTSD symptoms, anxiety, suicidal ideation and behaviour, and chronic pain severity.

The primary outcome measures will be assessed from baseline to day 140, while secondary outcome measures will be assessed at various intervals up to day 140. The study is estimated to start in December 2023 and conclude in June 2025, with an estimated enrolment of 160 participants.

This study is sponsored by Apex Labs Ltd. and aims to address the need for effective and safe treatments for severe depression in individuals with PTSD, potentially offering a novel therapeutic approach for this challenging condition.

Topic Depression PTSD
Compound Psilocybin Placebo
Country Canada
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